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Trodelvy



Gilead Sciences Ireland UCEU/1/21/1592/001

Main Information

Trade NameTrodelvy
Active SubstancesSacituzumab Govitecan
Dosage FormPowder for concentrate for solution for infusion
Licence HolderGilead Sciences Ireland UC
Licence NumberEU/1/21/1592/001

Group Information

ATC CodeL01 ANTINEOPLASTIC AGENTS
L01XF17 Sacituzumab Govitecan

Status

License statusAuthorised
Licence Issued22/11/2021
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Marketing StatusUnknown

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
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